Sjögren and Gynecologic Considerations

NCT05670535 | Completed

• 1 other identifier: E1-20-1290
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. It is called primary Sjögren's syndrome (pSS) in absence of another connective tissue disease. The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be involved which precede such as xerotrachea in upper airway, atrophic gastritis and pancreatitis in gastrointestinal tract, and dryness in vaginal mucosa. Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters.

Conditions

Primary Sjögren Syndrome; Vaginitis Candida; Vaginitis; Sexual Dysfunction

Keywords

Acute vaginitis; Dyspareunia; Gynecological complaints; Sexual dysfunction; Sjögren's Syndrome; Vaginal candidiasis

Outcome Measures

Primary Outcomes (6)

• Vaginal candidiasis

  Culture of swab sampling from vaginal fluid at Sabouraud dextrose agar plates incubated in CO2 for evaluation of candida

  20 minutes

• Acute vaginitis

  Laboratory assessment of vaginal swab sampling from vaginal fluid for bacterial vaginosis

  10 minutes

• Visual analogue scale for dyspareunia

  The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.

  20 minutes

• Visual analogue scale for vaginal dryness

  The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.

  20 minutes

• The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)

  The severity of clinical signs regarding Sjögren's Syndrome disease activity, scored between 0 (no symptoms) to 3 (worst symptoms) points.

  20 minutes

• The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

  he severity of patient reported symptoms regarding Sjögren's Syndrome, scored between 0 (no symptoms) to 10 (worst symptoms) points.

  20 minutes

Study Arms (2)

pSS group (Study group)

* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.

Other: Visual analogue scale (VAS) for dyspareunia; Other: Visual analogue scale (VAS) for vaginal dryness; Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI); Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

Women without pSS (Control group)

* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.

Other: Visual analogue scale (VAS) for dyspareunia; Other: Visual analogue scale (VAS) for vaginal dryness; Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI); Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)

Interventions

Visual analogue scale (VAS) for dyspareunia OTHER

Dyspareunia scores between 0 to 10 points

Women without pSS (Control group); pSS group (Study group)

Visual analogue scale (VAS) for vaginal dryness OTHER

Vaginal dryness scores between 0 to 10 points

Women without pSS (Control group); pSS group (Study group)

The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) OTHER

Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points

Women without pSS (Control group); pSS group (Study group)

The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) OTHER

Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points

Women without pSS (Control group); pSS group (Study group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study is designed as a prospective cohort study, to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). All the participants will be recruited from sexually active women with single sexual partner.

You may qualify if:

• All participants are recruited from women who consecutively applied to outpatient clinic.
• Normally menstruating women at reproductive age (without menopause) for all participants.
• Regular sexual activity with single sexual partner for all participants.
• Receiving only hydroxychloroquine sulfate treatment for women with pSS.
• Presence of the symptoms of vaginitis for all participants.
• Without any known disease including autoimmune disorders for women in control group.

You may not qualify if:

• Women with the pelvic anatomical structural abnormalities
• History of any type of cancer including gynecological cancers, chemotherapy, and/or radiotherapy,
• Endometriosis, chronic cervicitis, menopause, pregnancy, lactation, use of hormonal contraceptive medication, use of vaginal estrogen, pre-malign or malign cytology at Papanicolaou (PAP) smear, having intrauterine device,
• Smoking,
• Chronic diseases (diabetes mellitus, psychiatric disorders,
• Multiple sexual partners, sexually transmitted infections including gonorrhea, chlamydia, genital herpes, and/or mycoplasma, mixed vaginal infections,
• Urinary tract infection in last three months,
• Antibiotic medication at last one month,
• Administration of drugs which may lead vaginal dryness including antihistaminics, antidepressants, and anti-hypertensives,
• Treatment with glucocorticoids, biologic disease modifying anti-rheumatic drugs, or immune-suppressive agents at last three months
• Women who had sexual partners with any sexual dysfunction

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

• Mariette X, Criswell LA. Primary Sjogren's Syndrome. N Engl J Med. 2018 Mar 8;378(10):931-939. doi: 10.1056/NEJMcp1702514. No abstract available.

  PMID: 29514034 RESULT

• Priori R, Minniti A, Derme M, Antonazzo B, Brancatisano F, Ghirini S, Valesini G, Framarino-dei-Malatesta M. Quality of Sexual Life in Women with Primary Sjogren Syndrome. J Rheumatol. 2015 Aug;42(8):1427-31. doi: 10.3899/jrheum.141475. Epub 2015 Jul 1.

  PMID: 26136488 RESULT

• Mulherin DM, Sheeran TP, Kumararatne DS, Speculand B, Luesley D, Situnayake RD. Sjogren's syndrome in women presenting with chronic dyspareunia. Br J Obstet Gynaecol. 1997 Sep;104(9):1019-23. doi: 10.1111/j.1471-0528.1997.tb12060.x.

  PMID: 9307528 RESULT

• Brito-Zeron P, Baldini C, Bootsma H, Bowman SJ, Jonsson R, Mariette X, Sivils K, Theander E, Tzioufas A, Ramos-Casals M. Sjogren syndrome. Nat Rev Dis Primers. 2016 Jul 7;2:16047. doi: 10.1038/nrdp.2016.47.

  PMID: 27383445 RESULT

• ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. 2006 May;107(5):1195-1206. doi: 10.1097/00006250-200605000-00049.

  PMID: 16648432 RESULT

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Vaginitis; Sexual Dysfunction, Physiological; Dyspareunia; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Obstetrician and Gynecologist, Principal Investigator

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: March 1, 2021
• Primary Completion: October 15, 2022
• Study Completion: November 10, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)